An Open Letter from Dr. Brown Expressing Concern about a Recent FDA Action Related to ADHD

An open letter from Dr. Brown expressing concern about recent FDA approval of a diagnostic device for ADHD that is not adequately supported by research and may become a barrier to diagnosis for some.

July 22, 2013

An Open Letter to Margaret A. Hamburg, M.D. 

Commissioner of Food & Drug Administration of the U.S.

Dear Commissioner Hamburg:

On July 15, 2013, your agency issued a press release reporting that the “FDA permits marketing of the first brain wave test to help assess children and teens for ADHD.” In this action your agency, apparently on the basis of a single unpublished study of 275 children, has created significant risks for those affected with ADHD.

Although your press release said “allows marketing” of this device, radio, TV and print coverage of the news over the past week has trumpeted the message as “FDA has approved a brain wave test for ADHD.” For many, this is likely to be interpreted as meaning that the FDA has approved this device to be “safe and effective” for making a diagnosis of ADHD, just as medications approved by the FDA are taken to be safe and effective for treating a specific disorder. 

That press release reported “results showed that the use of NEBA” this newly approved device, “aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD.” This creates the false impression that within 15 or 20 minutes this device has the capacity to provide objective data which can make a more valid diagnosis than a clinician using the usual clinical measures for assessment. This creates a serious risk that a number of clinicians, parents, and others will give undue weight to that brief data sample and, on that basis, deny an ADHD diagnosis to a patient who warrants it or, perhaps, to diagnose someone with ADHD who does not, in fact, have it.  

Current research on ADHD has demonstrated that symptoms of this disorder tend to be situationally variable. DSM-5 states “Typically, symptoms (of ADHD) vary depending on context within a given setting. Signs of the disorder may be minimal or absent when the individual is… in a novel setting…or is interacting in one-to-one situations (e.g. the clinician’s office).”  Just as a brief structural brain image, e.g. SPECT scan, cannot determine a diagnosis of ADHD, so a sample of EEG data cannot provide clinically useful information about how the individual functions in meeting the multiple demands of daily life. Diagnosis of ADHD is essentially based upon careful assessment of the individual’s current history in multiple aspects of cognitive and behavioral functioning in school, work, family life and social relationships. 

As a clinician and researcher confronted daily with the frustrations and suffering of children and adults with ADHD, I urge your agency to reconsider its approval of this device so it does not become a barrier to those who need access to diagnosis and treatment for this complex and often persistent disorder.

Thomas E. Brown, Ph.D.

Associate Director

Yale Clinic for Attention & Related Disorders

Dept. of Psychiatry

Yale University School of Medicine

Related posts:

6 Responses to An Open Letter from Dr. Brown Expressing Concern about a Recent FDA Action Related to ADHD

  1. Dr. Brown –

    This is a fantastic letter. I have just shared this on my Facebook page that is a support network for almost 12,000 Moms, Dads, and loved ones to children affected by ADHD.

    I agree with your concerns, and I applaud your effort to make people aware of the very subtle, and profound messages implied from this story.

    Thank you for your great work and contribution to our field.

    Dr. Stern

  2. Gina Pera says:

    Thank you, Dr. Brown!

    I’ve been watching this “device” make its way through the channels with great skepticism.

    Since this announcement, I’ve been alarmed at many in the ADHD community welcoming this latest development, as if it’s great news. Some kind of scientific breakthrough.

    The ADHD “market” is hot right now, and exploitation is rampant. We should all be extremely discerning in deciding what to applaud.

    Thank you for taking the time to explain the implications of this device.

    Gina Pera

  3. EVA BELMAR. says:

    AM IN TOTAL AGREEMENT WITH DR. BROWN.
    I SUPPORT HIS REQUEST.
    DR.EVA BELMAR.
    NEUROPSYCHOLOGY.
    MEXICO CITY, MÉXICO.

  4. THANK YOU!! Will be sharing. Disheartening, isn’t it, how pervasive the ignorance in the face of so MUCH information – and how high “up” it goes?

    I agree with Gina’s comment. I, too, am alarmed at how uninformed those in the ADD community choose to remain – because it IS a choice – the data is out there and easy to locate. I do not get it – I NEVER will.

    ~~~~~
    Madelyn Griffith-Haynie, CMC, SCAC, MCC
    – ADD Coach Training Field founder; ADD Coaching co-founder –
    (blogs: ADDandSoMuchMore, ADDerWorld & ethosconsultancynz – dot com)
    “It takes a village to educate a world!”

  5. Hello my friend! I want to say that this article is awesome,
    nice written and include approximately all vital
    infos. I would like to see more posts like this.

  6. tmixes says:

    Wonderful blog you have here but I was wanting to know if you knew of any community forums that cover the same topics discussed here?

    I’d really love to be a part of online community where I can get advice from
    other experienced people that share the same interest. If you have any recommendations, please let me know.
    Cheers!

Leave a Reply

Your email address will not be published. Required fields are marked *